AmoyDx Accelerates Global Expansion in Companion Diagnostics Through Strategic Collaboration with Lilly Subsidiary Loxo Oncology

EO Intelligence Health, June 24 News,Amoy DiagnosticsPublish its andEli Lilly and CompanyAnnouncement on Subsidiary LOXO ONCOLOGY Entering into Clinical Research Collaboration for Targeted Therapies.The announcement stated that Amoy Diagnostics’ self-developed “AmoyDx Pan-RAS” and “AmoyDx EGFR Mutation Test” will serve as the companion diagnostic reagents for LOXO ONCOLOGY’s pan-cancer RET inhibitor “LOXO-292” in clinical trials across Asia. Furthermore, Amoy Diagnostics, LOXO ONCOLOGY, and PREMIA HOLDINGS (HONG KONG) LIMITED will jointly establish a clinical genetic testing platform serving Asian patients, adhering to the high standards of the Lung Cancer Project at the National Cancer Center Japan.

Amoy Diagnostics is a provider of comprehensive solutions for tumor gene testing in the field of companion diagnostics, primarily engaged in the research and development, production, sales, and services of molecular diagnostic products. Leveraging its technological advantages in nucleic acid molecular detection and nucleic acid purification platforms, it has developed 22 types of tumorPrecision MedicineMolecular Diagnostic Reagents.The products covered by this agreement include “AiHuiJian,” a multi-gene combined detection product based on the PCR platform, and “WeiHuiJian,” a 10-gene detection product based on the NGS platform. Both were approved for market launch in August and November of last year, respectively.

Partner for This CollaborationLOXO ONCOLOGYA star enterprise in the field of targeted therapies, it possesses a portfolio of multi-cancer targeted drugs including RET and NTRK inhibitors, and was acquired by Eli Lilly and Company for $8 billion in January 2019;PREMIA HOLDINGS(HONG KONG)LIMITEDEstablished in 2018, its core business is to accelerate the development of novel cancer therapies by providing an efficient clinical development platform in Asia.

Amoy Diagnostics stated that LOXO Oncology’s selection of the company as the companion diagnostics partner for the Asian clinical studies of its investigational targeted drug, LOXO-292, will help further enhance Amoy Diagnostics’ competitiveness in the Asian market and have a positive impact on the company’s future development. Additionally,Amoy Diagnostics has 22 single-gene or multi-gene combination testing reagents that have obtained NMPA registration certificates, providing a comprehensive product foundation for building a clinical genetic testing platform serving Asian patients.

Notably, this is not the first time Amoy Diagnostics has entered into a collaboration with a pharmaceutical giant. Previously,Amoy Diagnostics’ ROS1 Gene Fusion Detection Kit Facilitated the Success of Pfizer’s Crizotinib in Asia-Pacific Clinical Studies for First-Line Treatment of Patients with ROS1 Fusion-Positive Tumors, and has obtained medical device registration certificates in Japan, South Korea, and China's Taiwan region, while also being included in the national health insurance systems of Japan and South Korea. This demonstrates that such a collaborative model has now become its primary means of continuously expanding into overseas markets.

With the successive market launches of targeted oncology drugs and immunotherapies, coupled with declining treatment costs, companion diagnostics, as an essential diagnostic procedure for clinical medication, boast broad market prospects.According to Marketsand Markets, companion diagnostics will be one of the fastest-growing subsectors within the overall in vitro diagnostics (IVD) industry in the coming years. In 2022, the global market size for companion diagnostics is projected to reach USD 6.51 billion, with a compound annual growth rate (CAGR) of 20.1% from 2017 to 2022, significantly exceeding the 5.5% CAGR of the broader IVD industry.

In the Domestic MarketAmoy Diagnostics has further strengthened its marketing network, expanded market coverage and penetration, and improved its nationwide direct sales network to consolidate its market position. It has also implemented refined management of its lung cancer and non-lung cancer product lines, facilitating the rapid adoption of its products in the clinical market.

In the international market,Amoy Diagnostics has actively participated in clinical trials of originator drugs developed by pharmaceutical companies, thereby seeking approval as a bundled companion diagnostic kit. This approach to entering overseas markets has yielded favorable operational results in the short term; however, whether it can serve as a sustainable long-term strategy remains to be seen over time.

July 25-27, 2019, Yiou Health will host“GIIS 2019: The 4th China Summit on the Upgrading of the Big Health Industry”The summit, themed “Yanqi Health Talk: Healthcare Transformation from [Scale] to [Value],” focused on discussions around market environments, investment hotspots, and industrial transformations in four key sectors: healthcare big data, pharmaceutical innovation, private healthcare, and health technology.

Event Registration Link:https://www.iyiou.com/post/ad/id/785

Copyright Statement

Source: EqualOcean. Published with authorization from EqualOcean. All rights reserved by the original copyright holder. For reprints or content collaboration, please refer to the reprint guidelines; unauthorized reprints will be subject to legal action.